Randomised controlled trial of nocturnal insulin glargine versus human insulatard in combination with metformin in patients with type two diabetes currently treated with metformin/insulatard combination therapy
| ISRCTN | ISRCTN76123473 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76123473 |
| Secondary identifying numbers | N0237101842 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Niall Furlong
Scientific
Scientific
Research Fellow
Diabetes Centre
Whiston Hospital
Prescot, Merseyside
L35 5DR
United Kingdom
| Phone | +44 (0)151 426 1600 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of the present open-labelled, randomised controlled study is to examine effectiveness of insulin glargine in combination with metformin 1 g twice daily (bid) - 1 g three times a day (tds) compared with insulatard combined with metformin (same dose) in type two diabetic patients currently treated with insulatard/metformin combination therapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | Randomised controlled trial. Patients randomised to: 1. Nocturnal insulin glargine 2. Human insulatard in combination with metformin |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glargine, metformin, insulatard |
| Primary outcome measure | 1. Glycosylated haemoglobin (HbA1c) 2. Tasting blood glucose 3. Frequency of hypoglycaemia 4. Weight change |
| Secondary outcome measures | Well being and diabetes treatment satisfaction measured using appropriate validated questionnaires. |
| Overall study start date | 01/08/2001 |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | 80 patients. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2001 |
| Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Research Fellow
Prescot, Merseyside
L35 5DR
United Kingdom
L35 5DR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
St Helens and Knowsley Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
